Kornimate/medical-research-clean huggingface dataset:
phase 1 study of ds-8895a in subjects with advanced solid tumors

Conditions: Solid Tumors

Summary: this is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of ds-8895a in japanese subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. * eastern cooperative oncology group performance status(ps) of 0 or 1 exclusion criteria: * have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment: cardiac failure (nyha ≥ classiii), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia) * severe or uncontrolled concomitant disease. * clinically active brain metastases defined as symptomatic or requiring treatment.

Keywords: advanced solid tumor phase 1 oncology
neurx diaphram pacing system (dps) use in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this research study is to collect more information about the use, safety, and effectiveness of the neurx dps® in als patients.

characterize the safety and benefit of on-label humanitarian device exemption (hde) use of dps in patients with als who initiated noninvasive ventilation (niv).

Eligibility criteria:
inclusion criteria: * age 21 or older * familial or sporadic als diagnosed as possible, laboratory-supported probable, probable, or definite according to the world federation of neurology el escorial criteria * bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with phrenic nerve conduction studies * chronic hypoventilation was documented by at least one of the following: * mip (respiratory muscle strength) less than 60 cmh2o, or * forced vital capacity (fvc) less than 50% predicted, or * paco2 greater than or equal to 45 mmhg, or * nocturnal sao2 (arterial oxygen saturation) less than or equal to 88% for at least five continuous minutes * initiation of non-invasive ventilation at or before time of enrollment * suitable surgical candidate to receive diaphragm pacing stimulation * negative pregnancy test in female participants of childbearing potential (treatment group) * informed consent from patient or designated representative exclusion criteria: * fvc less than 45% predicted within 10 days prior to surgery. * participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study.

Keywords: diaphragm pacing
alternate day fasting combined with a high protein background diet

Conditions: Obesity

Summary: the aims of this study are as follows: aim 1: to examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (adf-hp) diet; aim 2: to examine the effects of an adf-hp diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).

background: accumulating evidence suggests that alternate day fasting (adf) is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk. adf regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated with a "fast day" where intake is limited to \~600 kcal over 24 h. what has yet to be elucidated is whether consuming a high protein diet (as meal replacements) during adf is effective for weight loss, weight maintenance, and metabolic disease risk reduction in individuals with obesity. objective: the aims of this study are as follows: aim 1: to examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (adf-hp) diet; aim 2: to examine the effects of an adf-hp diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance). methods: a 24-week, single-center, longitudinal pilot study will be conducted to test the study objectives. the trial will be divided into 2 consecutive intervention periods: (1) 12-week weight loss period, and (2) 12-week weight maintenance period. subjects with obesity will participate in an adf-hp: alternate day fasting-high protein diet: 600 kcal "fast day" alternated with ad libitum "feast day", 35% kcal as protein. adf-hp subjects will consume the optifast hp shake mix (nestle) on each day of the trial. body weight, insulin, glucose, and insulin resistance, will be measured at baseline, week 12, and week 24. significance: these findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.

Eligibility criteria:
inclusion criteria: * age between 18 to 65 years old * bmi between 30.0 and 49.9 kg/m2 * previously sedentary or lightly active exclusion criteria: * diabetic * history of binge eating disorder * taking weight loss-inducing medications * not weight stable for 3 months prior to the study (weight gain or loss \> 4 kg) * perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days) * pregnant or trying to become pregnant * night shift worker * smokers
preliminary study leading to prevention of pressure ulcers by the use of an on-board device : ergonomic assessment of wheelchair-seat pressures in spinal cord injured (sci) patients ( presdie)

Conditions: Pressure Ulcer

Summary: analysis of stored seat-pressures in sci patients during a 4-week use of an on-board device. during this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. a control is done every week and the device can be changed until it is returned at the end of the study period.

* inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events * 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control * return visit : device return, agenda return, skin control, seat-pressures control

Eligibility criteria:
inclusion criteria : * patient is male or female, aged ≥ 18 * patient accepting the initial assessment and the following visits during the protocol * written informed consent has been obtained * patient having a social assurance * spinal cord injury ≤ c6 stable spinal cord trauma \> 1 an * main mode of ambulation : own manual wheelchair exclusion criteria : * aged ≤ 18 * adults under guardianship * patients do not speak french, refusing or unable to be followed * pregnant or lactating women * person deprived of their liberty by judicial or administrative decision * person hospitalised without consent * pelvic pressure ulcer ongoing * cognitive disorder incompatible with the use of the device, understanding and conduct of the study

Keywords: pressure ulcer, spinal cord injury, on-board device
placebo modulation of orthodontic pain

Conditions: Pain

Summary: how placebo modulates orthodontic pain remains largely unknown. the present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fmri.

how placebo modulates orthodontic pain remains largely unknown. the present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fmri. 23 voluneers were recruited in a longitudinal fmri experiment. at both the baseline and the one-month follow-up, orthodontic separators were placed between right lower molars 24 hours before mri scans. at baseline, the subjects were scanned without placebo while all subjects took placebos half an hour before the scan at follow-up. scans include a bite/non-bite task fmri and a followed resting state fmri. a generalized linear model was used to identify pain-regulating network from task fmri, and functional connectivity analysis of pain related brain regions was performed to study the possible modulation of placebo on connectivity of pain-regulating networks using resting-state fmri.

Eligibility criteria:
inclusion criteria: * female, 20-25 years old; * right handed; * understand the visual analog scale; * no history of serious illness, surgery, psychiatric disorders or neurological; * no history of drug or alcohol abuse; * no maxillofacial diseases, agomphiasis, caries, metal filling material or crown; * individual normal occlusion with no orthodontic treatment history. exclusion criteria: * claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting * discomfort during the scan process or during menstruation.
therapeutic exercise on the psychological well-being of women victims of gender violence.

Conditions: Anxiety Disorders; Depressive Symptoms; Gender-based Violence

Summary: the scientific literature shows that women subjected to gender violence suffer a deterioration in mental health (anxiety, stress and depression). in particular, a recent study carried out in galicia found a high incidence of post-traumatic stress, depression and low self-esteem in women victims of gender violence. the efficacy of therapeutic exercise in depression and anxiety has been widely demonstrated, as has the link between gender violence and deterioration of mental health, with a high incidence of post-traumatic stress. however, research on the effect of therapeutic exercise in battered women is very limited. for this reason, the aim of the present project is to evaluate the effect of a therapeutic exercise program on mental health in women who have suffered gender violence.


Eligibility criteria:
inclusion criteria: * women of legal age with a history of gender-based violence who come to the women's center or are included in the women's center's programs. exclusion criteria: * consumption of alcohol or other drugs. * musculoskeletal disorders, recent surgery, as well as any physical problem that prevents exercise. * any medical contraindication to exercise. * pregnancy. * having any affirmative answer in the parq questionnaire (physical activity readiness questionnaire). * participants who do not have the capacity to consent to participate will be excluded.
characterization of at-risk population for pre-sacral tumor in currarino syndrome

Conditions: CURRARINO Syndrome; Sacrococcygeal Teratoma; Presacral Mass

Summary: contribute to support hypothesis of relationships between genes involve in oncogenesis and those involve in embryological development.

currarino syndrome (cs) (omim 176450) is a rare congenital disease described in 1981, as the association of, at least, three main clinical features: typical sacral malformation (sickled-shape sacrum or total sacral agenesis below s2), hindgut anomalies and pre-sacral tumor. to date, neurological defects, as tethered cord and/or lipoma of the filum or the conus, are up lighted to be as a fourth major clinical sign.in half of cases, cs is ascribed to heterozygous mutations of the hlxb9 gene (or mnx1 gene, omim 142994) located at 7q36, with an autosomal dominant mode of inheritance. the hlxb9 gene is involved in motoneurons and caudal development of the embryo. however, genetic heterogeneity is suspected, since patients without hlxb9 mutation harbour subtle phenotypic variations. presently, no other locus has been identified. the pre-sacral tumor develops in almost 80% of cs. when it is a teratoma (30% of cases), it may turn into malignancy in 1 to 4 % of cases, according to literature. as far as we know, no clinical, molecular or pathological marker is operational to predict tumoral evolution and give any prognosis. major aim of this study is to find out any correlation between clinical signs, constitutional and somatic genetic anomalies of hlxb9 gene and other candidate genes, and/or pathological features and tumoral evolution in cs. evaluation of the pre-sacral tumor evolution is based on local recurrence or distance metastasis after surgical removal. annual serum alpha-foeto-protein level monitoring is also performed, as the unique marker of teratoma.this study specifically required annual clinical examination and lumbar-sacral mri imaging, three blood samples at inclusion and an annual blood sample.this multicentric study will last for at least 6 years. eighty patients will be included and follow up for at least 3 years. finally, this study may help identify a group of at-risk patients for tumor development and malignant transformation if pre-sacral teratoma. it will also help define objective clinical, radiological, molecular, pathological and/or biological criteria for long lasting survey. in general, it may also contribute to support hypothesis of close relationships between genes involve in oncogenesis and those involve in embryological development.

Eligibility criteria:
inclusion criteria: * at least 1 out of the 4 major signs of currarino syndrome: 1. sacral agenesis 2. hindgut malformation or chronic constipation 3. presacral tumor and/or 4. tethecord syndrome and/or lipoma of the filum or the conus * anomaly genotyping hlxb9 without clinical expression exclusion criteria: - opposition to sign informed consent agreement

Keywords: currarino syndrome sacrococcygeal teratoma hlxb9 (mnx1) gene alpha foeto protein prognosis factors
association between haptoglobin genotype and brain swelling

Conditions: Intracerebral Hemorrhage

Summary: intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. brain injury from intracerebral hemorrhage occurs in two phases. the early phase involves the mechanical compression of brain tissue by the expanding hematoma. in a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. this study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.

intracerebral hemorrhage is bleeding into the brain parenchyma. it is a major cause of stroke, and is associated with significant morbidity and mortality. brain injury from intracerebral hemorrhage occurs in two phases. the early phase involves the mechanical compression of brain tissue by the expanding hematoma. in a later phase, brain edema, especially perihematomal edema, develops causing further compression that may lead to brain herniation and death. several factors are implicated in the development of brain edema, including inflammation resulting from the oxidative stress caused by iron-rich hemoglobin released from lysed erythrocytes in brain tissue. this study investigates the neuroprotective role of an acute phase reactant, haptoglobin, in minimizing the development of perihematomal edema following intracerebral hemorrhage. this protein protects brain tissue from hemoglobin degradation products by forming haptoglobin-hemoglobin complexes that are subsequently cleared by the spleen. notably, different alleles of haptoglobin exist in humans, with varying affinities for hemoglobin. investigating the association between the different alleles and the degree of perihematomal edema formation is the primary goal of this study. the investigators will also look at a marker of inflammation, matrix metalloproteinases, and analyze its level of expression in subjects with different alleles of haptoglobin.

Eligibility criteria:
inclusion criteria: * spontaneous intracranial or intraparenchymal hemorrhage * 18-85 years of age * hemorrhage occurred in a supratentorial location exclusion criteria: * inability to obtain consent within 3 days of hemorrhage onset * known pregnancy * therapeutic anticoagulation with lovenox, coumadin or heparin * prior history of therapeutic radiation to any area * brain tumor * hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation * central nervous system infection * subdural hematoma * subarachnoid hemorrhage * chronic immunosuppression, including steroids or chemotherapy agents * infratentorial location * unable to obtain mri due to mental status or other contraindication (metal, pacemaker, etc.)

Keywords: hemorrhage intracerebral hemorrhage (ich)
evaluation of the safety and effectiveness of the kinamed gem ceramic femoral component for total knee replacement

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the gem total knee system is similar to fda approved implants used in total knee replacement surgery. the hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.

due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (tha). use of a ceramic-polyethylene wear couple in total knee arthroplasty (tka) has shown promising laboratory and early clinical results. the use of ceramics in this study is intended to address long-term failure of tka due to osteolysis associated with polyethylene wear debris.

Eligibility criteria:
inclusion criteria: * skeletally mature * primary tka for osteoarthritis or post-traumatic arthritis of the knee joint * stable or reconstructable collateral and posterior cruciate ligaments * correctable deformity * intact quadriceps and hamstrings mechanisms * patella bone thick enough (at least 15 mm) after resection exclusion criteria: * previous tka * bilateral knee arthritis * non-availability for follow-up * mental incompetence or confinement * patients being treated with other investigational devices for same disorder * infection * osteoporosis, acute renal failure, or other disorders known to affect bone quality * charcot's or paget's disease * patient physical condition preventing use of appropriate size implant * disease conditions affecting blood supply to knee * insufficient bone quality or quantity * physical condition predisposing implant to extreme loads * history of septic knee arthritis * history of drug abuse

Keywords: total knee arthroplasty osteoarthritis ceramic bearing zirconia
non-drug study to assess the suitability of assessment scales in japanese individuals with down syndrome aged 6-30

Conditions: Down Syndrome

Summary: to evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with down syndrome aged 6-30.


Eligibility criteria:
inclusion criteria: * subjects may have standard trisomy 21, robertsonian translocation, isochromosome21,down syndrome with reciprocal translocation or mosaicism. * availability of parent or other reliable caregiver who agrees to accompany the subject to clinic visits, provide information about the subject's behavior and symptoms. * down syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate to the study provided they are on stable medication for at least 8 weeks prior to screening. exclusion criteria: individuals who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.
ombitasvir/abt-450 (paritaprevir)/ritonavir with dasabuvir and ribavirin (rbv) in treatment naive and treatment experienced genotype 1a hepatitis c virus infected adults

Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a

Summary: a study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis c virus (hcv) genotype (gt) 1a treatment-naïve and pegylated-interferon (pegifn)/ribavirin (rbv) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (rbv) for 12 weeks.

a study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with rbv treatment leading to sustained virologic response 12 weeks post-dosing (svr12) on the changes from baseline in ifn-stimulated gene (isg) expression in peripheral blood mononucleated cells (pbmcs) in hcv gt 1a-infected adult participants.

Eligibility criteria:
inclusion criteria: 1. screening laboratory result indicating hepatitis c viral (hcv) genotype (gt) 1a infection. 2. chronic hcv infection. 3. participants must be non-cirrhotic. 4. participants must be treatment-naïve or have documentation that they were adherent to prior pegifn/rbv combination therapy and meet the criteria of prior pegylated-interferon (pegifn)/ribavirin (rbv) treatment failure. 5. participants must meet specific human leukocyte antigen (hla) allele requirements. exclusion criteria: 1. women who are pregnant or breastfeeding. 2. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab) positive immunoassay. 3. clinically significant abnormalities or co-morbidities, other than hcv infection, that make the subject unsuitable for this study or treatment. 4. current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-hcv agents other than pegifn or rbv (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration. 5. history of solid organ transplant. 6. screening laboratory analysis that shows abnormal results.

Keywords: treatment naive interferon free hcv chronic hepatitis c hepatitis c genotype 1a hepatitis c pegylated-interferon (pegifn)/ribavirin (rbv) experienced